系统评价维持治疗对晚期非小细胞肺癌的临床疗效
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摘要
目的
应用Revman4.3.2进行Meta分析系统评价维持治疗对晚期非小细胞肺癌(NSCLC)的1年生存率、2年生存率及1年无进展生存期的影响,进而评价维持治疗对晚期非小细胞肺癌的临床疗效。
方法按照Cochrane协作网工作手册4.3.2的要求针对不同数据库制定不同的检索策略,检索的数据库有Cochrane数据库、EBSCO数据库、PubMed检索系统、ScienceDirect全文期刊数据库、OVID全文期刊数据库、Springrlink全文期刊数据库等。检索策略Pubmed:maintenance AND non small cell lung cancer AND randomized controlled trial.评价纳入研究的方法学质量,提取有效数据,采用RevMan4.3.2软件进行Meta分析。随机对照试验(RCT)。研究对象经细胞学或病理检查确诊的NSCLC患者,并经化疗初始治疗后缓解的患者。试验组干预措施化疗缓解后应用新一代化疗药作为维持治疗,对照组在化疗缓解后不予任何治疗或者两组同时进行的相同的最佳支持治疗。对诱导化疗方案并无限制。
结果
共检索到185篇文献,仅有14篇文献为随机对照试验符合纳入标准,共计7178例患者。RevMan4.3.2软件进行合并检验统计量,结果显示：NSCLC化疗缓解后应用维持治疗可以改善患者的1年无病进展率,RR为1.56(95%CI：1.33,1.82)。1年生存率RR为1.12(95%CI：1.00,1.26),2年生存率RR为1.20(95%CI：1.04,1.39)。结果可靠。
结论
非小细胞肺癌化疗缓解后应用维持化疗可以改善患者的1年无病进展率,1年及2年生存率,但是现有资料尚不足以下结论,需要进一步评价具体维持治疗方案的多中心大规模临床随机对照试验。
Objective
To evaluate the maintenance therapy for the prognosis of the patients with non-small cell lung cancer by meta-analysis.
Material and Method
Search all of the RCT on maintenance therapy for non-small cell lung cancer in MEDLINE, Cochrane Library, EBSCO database. A meta-analysis was completed by collecting numerical data based on inclusion and exclusion criteria from all papers available.
Results
The meta-analysis included 14 trials.A total of 7178 patients were included in the analysis.
Conclution
Induced chemotherapy with stabled disease followed by maintenance treatment could improve patients' 1-year progression-free survival、1-year overall survival and 2-year overall survival.
应用Revman4.3.2进行Meta分析系统评价维持治疗对晚期非小细胞肺癌(NSCLC)的1年生存率、2年生存率及1年无进展生存期的影响,进而评价维持治疗对晚期非小细胞肺癌的临床疗效。
方法按照Cochrane协作网工作手册4.3.2的要求针对不同数据库制定不同的检索策略,检索的数据库有Cochrane数据库、EBSCO数据库、PubMed检索系统、ScienceDirect全文期刊数据库、OVID全文期刊数据库、Springrlink全文期刊数据库等。检索策略Pubmed:maintenance AND non small cell lung cancer AND randomized controlled trial.评价纳入研究的方法学质量,提取有效数据,采用RevMan4.3.2软件进行Meta分析。随机对照试验(RCT)。研究对象经细胞学或病理检查确诊的NSCLC患者,并经化疗初始治疗后缓解的患者。试验组干预措施化疗缓解后应用新一代化疗药作为维持治疗,对照组在化疗缓解后不予任何治疗或者两组同时进行的相同的最佳支持治疗。对诱导化疗方案并无限制。
结果
共检索到185篇文献,仅有14篇文献为随机对照试验符合纳入标准,共计7178例患者。RevMan4.3.2软件进行合并检验统计量,结果显示：NSCLC化疗缓解后应用维持治疗可以改善患者的1年无病进展率,RR为1.56(95%CI：1.33,1.82)。1年生存率RR为1.12(95%CI：1.00,1.26),2年生存率RR为1.20(95%CI：1.04,1.39)。结果可靠。
结论
非小细胞肺癌化疗缓解后应用维持化疗可以改善患者的1年无病进展率,1年及2年生存率,但是现有资料尚不足以下结论,需要进一步评价具体维持治疗方案的多中心大规模临床随机对照试验。
Objective
To evaluate the maintenance therapy for the prognosis of the patients with non-small cell lung cancer by meta-analysis.
Material and Method
Search all of the RCT on maintenance therapy for non-small cell lung cancer in MEDLINE, Cochrane Library, EBSCO database. A meta-analysis was completed by collecting numerical data based on inclusion and exclusion criteria from all papers available.
Results
The meta-analysis included 14 trials.A total of 7178 patients were included in the analysis.
Conclution
Induced chemotherapy with stabled disease followed by maintenance treatment could improve patients' 1-year progression-free survival、1-year overall survival and 2-year overall survival.
引文
1 Karen Kelly,Kari Chansky,Laurie E,et al:Phase III Trial of Maintenance Gefitinib or Placebo After Concurrent Chemoradioherapy and Docetaxel Consolidation in loperable Stage III Non-Small-Cell Lung Cancer:SWOG S0023, J Clin Oncol 26:1-7,2008
2 Koji Takeda,Toyoaki Hida,Tosiya Sato,et al:Randomized Phase Ⅲ Trial of Platinum-Doublet Chemotherapy Followed by Gefitinib Compared With Continued Platinum-Doublet Chemotherapy in Japaness Patients with Advanced Non-Small-Cell Lung Cancer:Results of a West Japan Thoracic Oncology Group Trial (WJTOJ0203), J Clin Oncol 27:1-9,2009
3 Panos M.Fridas,Shaker R.Dakhil,Alan P.Lyss,et al:Phase Ⅲ Study of Immediate Compared With Delayed Docetaxel After Front-Line Therapy With Gemcitabine Plus Carboplatin in Advanced Non-Small-Cell Lung Cancer, J Clin Oncol 27:591-598,2008
4 Thomas Brodowicz,Maciej Krzakowski,Matjaz Zwitter,et al:Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in Advanced Non-Small-Cell Lung Cancer:A phase Ⅲ trial, Lung cancer2006;52:155-163.
5 Virginie Westeel,Elisabeth Quoix,Denis Moro-Sibilot,et al:Randomized Study of Maintenance Vinorelbine in Respond-ers With Advanced Non-Small-Cell Lung Cancer,Journal of the National Cancer Institute 7,499-506,2005
6 Tudor Ciuleanu, Thomas Brodowicz, Christoph Zielinski,et al:Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer:a randomised, double-blind, phase 3 study Lancet 2009; 374:1432-40
7 Elizabeth A. Johnsona,*, Randolph S. Marksb, Sumithra J. Mandrekarb,Phase III randomized, double-blind study of maintenance CAI or placebo in patients with advanced non-small cell lung cancer (NSCLC) after completion of initial therapy (NCCTG 97-24-doi:10.1016/j.lungcan.2007.10.003
8 F. Cappuzzol, B. Coudert2, R. Wierzbicki3, et al:Overall survival analyses from the SATURN phase III placebocontrolled study of erlotinib as first-line maintenance therapy in advanced non-small-cell lung cancer (NSCLC)J Clin Oncol 27:15s,2009 (suppl; abstr 8001)
99 Chandra P. Belani, John Barstis, Michael C. Perry,et al:Multicenter, Randomized Trial for Stage ⅢB or Ⅳ Non-Small-Cell Lung Cancer Using Weekly Paclitaxel and Carbopl-atin Followed by Maintenance Weekly Paclitaxel or Observation DOI: 10.1200/JCO.2003.02.563
10 Yvon Cormier, Peter Ellis, Allan Price,Randomized Phase ⅡB Trial of BLP25 Liposome Vaccine in Stage IIIB and IV Non-Small-Cell Lung Cancer DOI:10.1200/JCO.2005.13.011
11 Siow Ming Lee, Robin Rudd, Penella J. Woll,Randomized Double-Blind Placebo-Controlled Trial of Thalidomide in Combination With Gemcitabine and Carboplatin in Advanced Non-Small-Cell Lung Cancer DOI:10.1200/JCO.2009.21.9733
12 Roy S. Herbst, Giuseppe Giaccone, Joan H. Schiller,Gefitinib in Combination With Paclitaxel and Carboplatin in Advanced Non-Small-Cell Lung Cancer:A Phase Ⅲ Trial-INTACT 2 DOI:10.1200/JCO.2005.02.
13 By Rowan T. Chlebowski, Linda Bulcavage,Hydrazine Sulfate Influence on Nutritional Status and Survival in Non-Small-Cell Lung Cancer J Clin Oncol 8:9-15.
14庄莉,王清泉,影响非小细胞肺癌维持化疗疗效的相关因素探讨昆明医学院学报2009,(6)：76—79
15王晓红,李凯,黄颖等,健择单药维持治疗初治有效的晚期非小细胞肺癌近期疗效观察内蒙古医学杂志Inner Mongolia Med J 2008年第40卷第10期1199-1201
16张珍等.健择／顺铂一线化疗后健择维持治疗晚期非小细胞肺癌.现代中西医结合杂志,2008 Jul,17(21)3311-3312
17 Roy S, Herbst, Diane Prager, Robert Hermann, et al:TRIBUTE:A Phase Ⅲ Trial of Erlotinib Hydrochloride (OSI-774) Combined With Carboplatin and Paclitaxel Chemotherapy in Advanced Non-Small-Cell Lung Cancer DOI:10.1200/JCO.2005.02.840
18 Fausto Petrelli,Mara Ghilardi,Marco Cremonesi,et al:Is there a role for maintenance therapy in non-small lung cancer? An emerging issue Expert Rev Anticancer Ther 9(10) 1455-1465 (2009)
19 Goldie JH, Coldman AJ.A mathematical model for relating the drugSensitivity of tumors to theirs spontaneous mutation rate.Cancer TreatRep,1979,63(11-12):1727
20吴一龙肿瘤突破传统引领未来——回望厄洛替尼(特罗凯)中国肺癌论坛Ⅲ中国医学论坛报／2009年／11月／26日／第B06版
21 Tony S. K. Mok, MD1 and Suresh S. Ramalingam, MD2 Maintenance Therapy in Nonsmall-Cell Lung Cancer,A New Treatment Paradigm Cancer 2009; 115:5143-54.
22 22Shadia I. Jalal, Foluso O. Ademuyiwa and Nasser H. Hanna.:The role of maintenance chemotherapy in advanced nonsmall cell lung cancer.Current Opinion in Oncology 2009, 21:110-115
23 23Jadad AR,Moore RA,Carroll D,et al.Assessing the quality of reports of randomized clinical trials:is blinding necessary[J].Control Clin Trials,1996,12(17):1-12.
24陆舜李子明2009ASCO非小细胞肺癌临床研究点评Journal of China Prescription Drug 2009.8 No.89
25罗吕宏综述范云审校.进展期非小细胞肺癌的维持治疗国际肿瘤学杂志2009年3月第36卷第3期205-208
26徐崇锐非小细胞肺癌维持治疗的曙光来自2009ASCO的最新报道 循证医学2009年6月第3期
1白维君,张霞,王大中进展期非小细胞肺癌维持治疗进展医学与哲学(临床决策论坛版)2009年6月第30卷第6期总第383期
2 Goldie JH, Coldman AJ. A mathematic model for relating the drug sensitivity of tumors to their spontaneous mutation rate. Cancer Treat Rep,1979,63(11-12):1727-1733.
3 Panos M.Fidias,Shaker R.Dakhil,Alan P.Lyss,et al:Phase III Study of Immediate Compared With Delayed Docetaxel After Front-Line Therapy With Gemcitabine Plus Carboplatin in Advanced Non-Small-Cell Lung Cancer, J Clin Oncol 27:591-598,2008
4 Tudor Ciuleanu, Thomas Brodowicz, Christoph Zielinski,et al:Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer:a randomised, double-blind, phase 3 study Lancet 2009; 374:1432-40
5 Thomas Brodowicz,Maciej Krzakowski,Matjaz Zwitter,et al:Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in Advanced Non-Small-Cell Lung Cancer:A phase Ⅲ trial, Lung cancer2006;52:155-163.
6 Roy S. Herbst, Diane Prager, Robert Hermann, et al:TRIBUTE:A Phase III Trial of Erlotinib Hydrochloride (OSI-774) Combined With Carboplatin and Paclitaxel Chemotherapy in Advanced Non-Small-Cell Lung Cancer DOI:10.1200/JCO.2005.02.840
7吴一龙 突破传统引领未来——回望厄洛替尼(特罗凯)中国肺癌论坛Ⅲ中国医学论坛报／2009年／11月／26日／第B06版肿瘤
8秦宝丽,椰慧楠,宿濛 非小细胞肺癌靶向药物治疗争论热点医学与哲学(临床决策论坛版)2009年6月第30卷第6期总第383期
9 Karen Kelly,Kari Chansky,Laurie E,et al:Phase Ⅲ Trial of Maintenance Gefitinib or Placebo After Concurrent Chemoradioherapy and Docetaxel Consolidation in Ioperable Stage Ⅲ Non-Small-Cell Lung Cancer:SWOG S0023, J Clin Oncol 26:1-7,2008
10 Roy S. Herbst, Giuseppe Giaccone, Joan H. Schiller,Gefitinib in Combination With Paclitaxel and Carboplatin in Advanced Non-Small-Cell Lung Cancer:A Phase Ⅲ Trial-INTACT 2 DOI:10.1200/JCO.2005.02.
2 Koji Takeda,Toyoaki Hida,Tosiya Sato,et al:Randomized Phase Ⅲ Trial of Platinum-Doublet Chemotherapy Followed by Gefitinib Compared With Continued Platinum-Doublet Chemotherapy in Japaness Patients with Advanced Non-Small-Cell Lung Cancer:Results of a West Japan Thoracic Oncology Group Trial (WJTOJ0203), J Clin Oncol 27:1-9,2009
3 Panos M.Fridas,Shaker R.Dakhil,Alan P.Lyss,et al:Phase Ⅲ Study of Immediate Compared With Delayed Docetaxel After Front-Line Therapy With Gemcitabine Plus Carboplatin in Advanced Non-Small-Cell Lung Cancer, J Clin Oncol 27:591-598,2008
4 Thomas Brodowicz,Maciej Krzakowski,Matjaz Zwitter,et al:Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in Advanced Non-Small-Cell Lung Cancer:A phase Ⅲ trial, Lung cancer2006;52:155-163.
5 Virginie Westeel,Elisabeth Quoix,Denis Moro-Sibilot,et al:Randomized Study of Maintenance Vinorelbine in Respond-ers With Advanced Non-Small-Cell Lung Cancer,Journal of the National Cancer Institute 7,499-506,2005
6 Tudor Ciuleanu, Thomas Brodowicz, Christoph Zielinski,et al:Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer:a randomised, double-blind, phase 3 study Lancet 2009; 374:1432-40
7 Elizabeth A. Johnsona,*, Randolph S. Marksb, Sumithra J. Mandrekarb,Phase III randomized, double-blind study of maintenance CAI or placebo in patients with advanced non-small cell lung cancer (NSCLC) after completion of initial therapy (NCCTG 97-24-doi:10.1016/j.lungcan.2007.10.003
8 F. Cappuzzol, B. Coudert2, R. Wierzbicki3, et al:Overall survival analyses from the SATURN phase III placebocontrolled study of erlotinib as first-line maintenance therapy in advanced non-small-cell lung cancer (NSCLC)J Clin Oncol 27:15s,2009 (suppl; abstr 8001)
99 Chandra P. Belani, John Barstis, Michael C. Perry,et al:Multicenter, Randomized Trial for Stage ⅢB or Ⅳ Non-Small-Cell Lung Cancer Using Weekly Paclitaxel and Carbopl-atin Followed by Maintenance Weekly Paclitaxel or Observation DOI: 10.1200/JCO.2003.02.563
10 Yvon Cormier, Peter Ellis, Allan Price,Randomized Phase ⅡB Trial of BLP25 Liposome Vaccine in Stage IIIB and IV Non-Small-Cell Lung Cancer DOI:10.1200/JCO.2005.13.011
11 Siow Ming Lee, Robin Rudd, Penella J. Woll,Randomized Double-Blind Placebo-Controlled Trial of Thalidomide in Combination With Gemcitabine and Carboplatin in Advanced Non-Small-Cell Lung Cancer DOI:10.1200/JCO.2009.21.9733
12 Roy S. Herbst, Giuseppe Giaccone, Joan H. Schiller,Gefitinib in Combination With Paclitaxel and Carboplatin in Advanced Non-Small-Cell Lung Cancer:A Phase Ⅲ Trial-INTACT 2 DOI:10.1200/JCO.2005.02.
13 By Rowan T. Chlebowski, Linda Bulcavage,Hydrazine Sulfate Influence on Nutritional Status and Survival in Non-Small-Cell Lung Cancer J Clin Oncol 8:9-15.
14庄莉,王清泉,影响非小细胞肺癌维持化疗疗效的相关因素探讨昆明医学院学报2009,(6)：76—79
15王晓红,李凯,黄颖等,健择单药维持治疗初治有效的晚期非小细胞肺癌近期疗效观察内蒙古医学杂志Inner Mongolia Med J 2008年第40卷第10期1199-1201
16张珍等.健择／顺铂一线化疗后健择维持治疗晚期非小细胞肺癌.现代中西医结合杂志,2008 Jul,17(21)3311-3312
17 Roy S, Herbst, Diane Prager, Robert Hermann, et al:TRIBUTE:A Phase Ⅲ Trial of Erlotinib Hydrochloride (OSI-774) Combined With Carboplatin and Paclitaxel Chemotherapy in Advanced Non-Small-Cell Lung Cancer DOI:10.1200/JCO.2005.02.840
18 Fausto Petrelli,Mara Ghilardi,Marco Cremonesi,et al:Is there a role for maintenance therapy in non-small lung cancer? An emerging issue Expert Rev Anticancer Ther 9(10) 1455-1465 (2009)
19 Goldie JH, Coldman AJ.A mathematical model for relating the drugSensitivity of tumors to theirs spontaneous mutation rate.Cancer TreatRep,1979,63(11-12):1727
20吴一龙肿瘤突破传统引领未来——回望厄洛替尼(特罗凯)中国肺癌论坛Ⅲ中国医学论坛报／2009年／11月／26日／第B06版
21 Tony S. K. Mok, MD1 and Suresh S. Ramalingam, MD2 Maintenance Therapy in Nonsmall-Cell Lung Cancer,A New Treatment Paradigm Cancer 2009; 115:5143-54.
22 22Shadia I. Jalal, Foluso O. Ademuyiwa and Nasser H. Hanna.:The role of maintenance chemotherapy in advanced nonsmall cell lung cancer.Current Opinion in Oncology 2009, 21:110-115
23 23Jadad AR,Moore RA,Carroll D,et al.Assessing the quality of reports of randomized clinical trials:is blinding necessary[J].Control Clin Trials,1996,12(17):1-12.
24陆舜李子明2009ASCO非小细胞肺癌临床研究点评Journal of China Prescription Drug 2009.8 No.89
25罗吕宏综述范云审校.进展期非小细胞肺癌的维持治疗国际肿瘤学杂志2009年3月第36卷第3期205-208
26徐崇锐非小细胞肺癌维持治疗的曙光来自2009ASCO的最新报道 循证医学2009年6月第3期
1白维君,张霞,王大中进展期非小细胞肺癌维持治疗进展医学与哲学(临床决策论坛版)2009年6月第30卷第6期总第383期
2 Goldie JH, Coldman AJ. A mathematic model for relating the drug sensitivity of tumors to their spontaneous mutation rate. Cancer Treat Rep,1979,63(11-12):1727-1733.
3 Panos M.Fidias,Shaker R.Dakhil,Alan P.Lyss,et al:Phase III Study of Immediate Compared With Delayed Docetaxel After Front-Line Therapy With Gemcitabine Plus Carboplatin in Advanced Non-Small-Cell Lung Cancer, J Clin Oncol 27:591-598,2008
4 Tudor Ciuleanu, Thomas Brodowicz, Christoph Zielinski,et al:Maintenance pemetrexed plus best supportive care versus placebo plus best supportive care for non-small-cell lung cancer:a randomised, double-blind, phase 3 study Lancet 2009; 374:1432-40
5 Thomas Brodowicz,Maciej Krzakowski,Matjaz Zwitter,et al:Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in Advanced Non-Small-Cell Lung Cancer:A phase Ⅲ trial, Lung cancer2006;52:155-163.
6 Roy S. Herbst, Diane Prager, Robert Hermann, et al:TRIBUTE:A Phase III Trial of Erlotinib Hydrochloride (OSI-774) Combined With Carboplatin and Paclitaxel Chemotherapy in Advanced Non-Small-Cell Lung Cancer DOI:10.1200/JCO.2005.02.840
7吴一龙 突破传统引领未来——回望厄洛替尼(特罗凯)中国肺癌论坛Ⅲ中国医学论坛报／2009年／11月／26日／第B06版肿瘤
8秦宝丽,椰慧楠,宿濛 非小细胞肺癌靶向药物治疗争论热点医学与哲学(临床决策论坛版)2009年6月第30卷第6期总第383期
9 Karen Kelly,Kari Chansky,Laurie E,et al:Phase Ⅲ Trial of Maintenance Gefitinib or Placebo After Concurrent Chemoradioherapy and Docetaxel Consolidation in Ioperable Stage Ⅲ Non-Small-Cell Lung Cancer:SWOG S0023, J Clin Oncol 26:1-7,2008
10 Roy S. Herbst, Giuseppe Giaccone, Joan H. Schiller,Gefitinib in Combination With Paclitaxel and Carboplatin in Advanced Non-Small-Cell Lung Cancer:A Phase Ⅲ Trial-INTACT 2 DOI:10.1200/JCO.2005.02.